Home NDC 71770-120 Siklos
Product NDC 71770-120
11-digit product format 717700120
Labeler code 71770
Product ID 71770-120_47d0b61d-ad65-d2e0-e063-6294a90afe50
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydroxyurea
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Medunik
Application NDA208843
Marketing category NDA
Marketing start 2018-04-15
Substance HYDROXYUREA
Active strength 1000 mg/1
Pharmacologic classes Antimetabolite [EPC], Urea [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208843-001 SIKLOS HYDROXYUREA 100MG TABLET / ORAL RLD 2017-12-21 N208843-002 SIKLOS HYDROXYUREA 1GM TABLET / ORAL RLD, RS 2017-12-21
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208843-002 SIKLOS 1GM TABLET / ORAL RLD 2017-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208843-001 SIKLOS 100MG TABLET / ORAL RLD 2017-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208843-002 SIKLOS 1GM TABLET / ORAL RLD, RS 2017-12-21 bb7c543d1eb4…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Siklos
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYUREA 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X6Q56QN5QC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283475 Internal RxNorm lookup 1999308 Internal RxNorm lookup 1999314 Internal RxNorm lookup 1999316 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71770-120-30 Siklos 30 in 1 BOTTLE TABLET, FILM COATED 30 13 71770-120-30 Siklos 1 in 1 CARTON TABLET, FILM COATED 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71770-120 SIKLOS (HYDROXYUREA) TABLET, FILM COATED [MEDUNIK] 12 Current NDC, Legacy NDC, 2 package rows 20250207_76957c0d-0f98-4376-bb06-eee651adc09d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71770-120-30 71770012030 1 BOTTLE in 1 CARTON (71770-120-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-04-15 0000-00-00 No No Current